Botox was just approved by the FDA for the treatment of chronic migraine headaches. This is great news to the more than 3 million chronic headache sufferers in the US (people who have more than 15 days with headaches each month). In Dr. Mauskop’s opinion Botox is one of the most effective treatments for frequent and severe headaches and it is the first treatment approved FDA for chronic migraines. Dr. Mauskop was one of the first headache specialists to begin using this treatment more than 15 years ago. He has published several scientific articles and book chapters on the use of Botox for headaches. His most recent chapter on Botox for headaches was just published a month ago in the 97th volume of the Handbook of Neurology (Elsevier). Dr. Mauskop has trained over 200 doctors from all across the US, Canada and Europe who traveled to the New York Headache Center to learn this technique. Initial reports of the use of Botox for headaches were met with disbelief, while strong skepticism about the efficacy of this treatment persisted for many years. The main reason for this skepticism was the fact that migraine headaches are known to originate in the brain, while Botox affects only muscles and nerves on the outside of the skull. A large amount of research led to our current understanding of how Botox works: while the brain begins the headache process, it requires feedback from nerves and muscles on the surface of the head. By blocking activation of the nerves and muscles the feedback loop remains open and the headache does not occur. After the first few treatments some patients still develop a migraine aura or just a sensation that the headache is about to start, but it does not. After repeated treatments even the auras and this sensation stops occurring. Botox seems to be effective in 70% of patients, which is a rate significantly higher than with any preventive migraine medications, such as Topamax (topiramate), Depakote (divalproex sodium), Inderal (propranolol), or Neurontin (gabapentin). These drugs are effective in less than 50% of patients who try them. The other 50% do not respond or develop unacceptable side effects. Lack of serious side effects is another big advantage of Botox over medications. Botox can cause cosmetic side effects, such as a surprised look, droopy eyelids, or one eyebrow being higher than the other. These and other side effects become less common as the doctor who performs them becomes more experienced. Occasionally, patients develop a headache from being stuck with a needle. This is also uncommon because the needle is very thin and if done correctly, the procedure usually causes very little pain. The effect of Botox begins about 5-6 days after the injections, but the improvement continues to occur for 3 months, at which point the second treatment is given. Some patient require Botox injections at 2 month intervals. Published studies have shown that the second treatment is usually more effective than the first and the third one is better than the second. After several treatments some people improve completely (a small percentage of patients stop having all of their headaches after the first treatment). Dr. Mauskop’s experience suggests that children as young as 10 who suffer from daily headaches also respond well to Botox injections. The major drawback of Botox is its cost. However, several insurance companies have been paying for this treatment and with the FDA approval most of them will have to cover this treatment for patients with chronic (more than 15 days a month) headaches.
Read MoreA new treatment for motion sickness in patients with migraines was reported by a group of doctors from Pittsburgh. Giving migraine sufferers who are prone to motion sickness a migraine drug, rizatriptan (Maxalt) prevented motion sickness . There were 25 subjects in the study and 15 of them developed motion sickness after being rotated in the darkness. Of these 15 patients, 13 showed decreased motion sickness after being pretreated with rizatriptan. This was a small study and not all patients benefited, but this is an option that should be considered in patients who suffer from severe motion sickness. It is likely that the effect is not specific to rizatriptan, but that sumatriptan (Imitrex), eletriptan (Relpax) and other triptans are also effective. However, just like when treating migraine attacks, it is possible that some patients will respond better to one triptan and others to another.
Read MoreAspirin is as effective as Imitrex (sumatriptan) in the treatment of migraine headaches with fewer side effects, according to an authoritative Cochrane review published earlier this year. The review examined 13 high-quality studies which involved 4,222 patients. Having such a large number of patients in well-conducted studies makes the data highly reliable. Some of the studies utilized 900 mg of aspirin and some 1,000 mg, some with and some without a nausea medicine, metoclopramide (Reglan). Aspirin was compared to both Imitrex, 50 or 100 mg and placebo. The authors concluded that “there are no major differences between aspirin with or without metoclopramide and sumatriptan 50 mg or 100 mg. Adverse events with short-term use are mostly mild and transient, occurring slightly more often with aspirin than placebo, and more often with sumatriptan 100 mg than with aspirin.
There are over 4 million chronic migraine sufferers in the US. Chronic migraine is defined as a headache with migrainous features, which occurs on more than 15 days each month. Many of these chronic migraine patients we see at the New York Headache Center have daily headaches. By the time they come to our Center, many have seen several doctors, including neurologists and found no relief from a variety of drugs. A new book just published by Oxford University Press may help doctors who care for headache patients to provide better care. The book is Refractory Migraine, Mechanisms and Management. Dr. Mauskop and Dr. Sun-Edelstein contributed a chapter to this book: Nonpharmacological Treatment for Refractory Migraine: Acupuncture, Vitamins and Minerals and Lifestyle Modifications. An important message contained in the chapter and the one we always stress to our patients is that the best way to approach a refractory headache is not by trying one drug after another, but by combining drugs with nonpharmacological treatments, such as biofeedback, magnesium, other supplements, Botox injections, acupuncture and other therapies.
Read MoreAspirin and similar anti-inflammatory drugs have been proven to be effective for many migraine sufferers. In a recent report 1,000 mg of aspirin was found to be as effective as 100 mg of sumatriptan (Imitrex) with fewer side effects. Cambia is a new prescription drug, which was recently approved by the FDA specifically for the treatment of migraine headaches. The active ingredient in this drug is diclofenac, which is also sold under Voltaren and Cataflam names. But unlike other forms of diclofenac, Cambia is a powder which patients are supposed to dissolve in a glass of water and drink it. Drinking a solution rather than swallowing a pill speeds absorption of the drug, which can make a difference for those migraine sufferers who need to catch their attacks early, or drugs don’t help. The drug has a “black box” warning, which cautions about possible cardiovascular side effects, as well as gastro-intestinal side effects, including bleeding and ulcers. The cardiovascular side effects of diclofenac are similar to those of Vioxx which was taken off the market. Other NSAIDs also carry risk of cardiovascular (and GI) side effects, but their risk is lower. The only NSAID without cardiovascular risks is aspirin. In fact it is used to prevent strokes and heart attacks. Aspirin is also the only drug which prevents the development of rebound headaches – worsening of headaches from frequent intake of a headache medicines or caffeine.
Read MoreSevere migraines are often accompanied by nausea and vomiting, making oral medications ineffective. Sumatriptan (Imitrex) and Zomig (zolmitriptan) are available in a nasal spray and Imitrex also as an injection (a needleless injection, Sumavel was launched recently). Nasal spray is not well absorbed and does not work well for many (in my experience, Zomig spray is somewhat better than Imitrex). Injections work fast, but are painful (even the needleless injection hurts) and expensive. Another way to get medicine into the body is rectally. Rectal suppositories are absorbed very quickly and more consistently than nasal sprays. Europeans are much more receptive to this route of administration than the Americans. A group of Italian researchers compared the effect of a suppository containing 25 mg of sumatriptan with a 50 mg tablet. The suppository was slightly more effective than the tablet. Imitrex suppositories are not available, but so called compounding pharmacies can prepare a suppository of any medication, if doctor writes an order. With Imitrex going generic, the price should be more affordable.
There are two other products in development (not yet available), which will bypass oral route – a sumatriptan skin patch and an inhaler of dihydroergotamine (Levadex). The patch is somewhat large and may be awkward to use, while the inhaler is much more promising. Inhaling a drug into the lungs provides very fast onset of action, faster than subcutaneous injection of Imitrex. According to the published data the efficacy of Levadex is very good with few side effects.
Read MoreVertigo is a common complaint of migraine patients. Ear-nose-throat specialists at the University of Pisa examined 22 patients with migraine headaches who complained of vertigo and 22 who did not, as well as 22 control subjects without migraines. They found that in both groups of patients with migraines a third had abnormal vestibular function on laboratory testing. In half of the patients in both groups the abnormality was in the inner ear (peripheral dysfunction) and in half in the brain (central dysfunction). This study confirms that both central and peripheral vertigo are common in migraine patients, whether they complain of vertigo or not. The most important question patients ask is what can we do about it. Fortunately, once migraines are brought under control, vertigo also subsides.
Read MoreIt is very exciting to finally have two published studies (PREEMPT 1 and PREEMPT 2) which provide definitive proof that Botox is effective for chronic migraine headaches. More than 15 years ago a plastic surgeon in California, Bill Binder reported that many of his patients treated with Botox for wrinkles found relief from headaches. Everyone was very skeptical, but having many patients who failed every other treatment and having learned that Botox is very safe if used properly, I decided to try it. To my great surprise Botox worked exceptionally well. My most dramatic experience was in a 76-year-old woman who suffered from daily headaches for 60 years. She had failed a long list of medications, nerve blocks, acupuncture and other treatments. After the first Botox treatment, for the first time in 60 years she went for three months without a single headache. Her neurologist came to my office to learn the technique I developed and has been using Botox in his practice ever since. More than 200 doctors from around the world came to our Center to learn how to use Botox for headaches. They were all searching for new treatments for their desperate patients. At the same time most of the medical community had remained very skeptical and dismissive of this approach. They could not believe that Botox could help headaches and wanted to see double-blind, placebo-controlled trials before using it in their patients. Well, now they have it, but over the past 15 years many of their patients could have benefited from this safe and effective treatment. Yes, we do need proof that any new treatment works, but when this treatment is safe and there are no better alternative, it is appropriate to try it before definitive proof is available. We hope that these two studies will lead to the FDA approval of Botox for the treatment of chronic migraines before the end of 2010, which will make it easier for patients to obtain insurance reimbursement.
Read MoreA recent study by Dr. Bigal and his colleagues just published in Neurology compared more than 6,000 migraine sufferers with over 5,000 matched control subjects without migraines. They discovered that people with migraine with aura and to a lesser extent those with migraine without aura are significantly more likely to have strokes, heart attacks, hypertension, poor circulation, diabetes, and high cholesterol. This clearly does not mean that migraine causes all these diseases, but only that if you have one you are more likely to have the other. It is important to recognize this association in migraine sufferers in order to regularly screen them for these conditions. We know that controlling diabetes, high blood pressure, and high cholesterol can prevent strokes, heart attacks and poor circulation in extremities. We also recommend that women who have migraine with aura should not take estrogen-based oral contraceptives or hormone replacement therapy since estrogen in these women also increases the risk of strokes. All migraine suffererss (and everyone else) should not smoke and exercise regularly, which also reduces the risk of the conditions mentioned above.
Read MoreSome headaches, usually migraines, do not respond to the usual over-the-counter and even prescription headache medications. Once it is clear that there is no serious underlying cause, such as an aneurysm, several injectable medications can be given in an emergency room (during office hours at the New York Headache Center we also give injections in the office). These medicines may include intravenous injections of: magnesium sulfate (which is not a medication, but a mineral), sumatriptan (Imitrex, which can be self-injected by patients at home), ketorolac (or it is also called Toradol, which is a drug in the aspirin family), dexamethasone (Decadron, a steroid drug, which can help pain of almost any type, but cannot be given for long periods of time), prochlorperazine (or Compazine, which is a nausea medication but can help pain as well), valproate sodium (Depacon), and several other drugs.
Read MoreDuring pregnancy, two thirds of women stop having migraine headaches. However, one third continues to have them, and sometimes even worsen during pregnancy. As a general rule, only acetaminophen (Tylenol) is considered safe, but for most migraine sufferers it is completely ineffective. Codeine is also benign, but it also either does not work or causes side effects, such as nausea and sedation. Triptans, such as sumatriptan (Imitrex), rizatriptan (Maxalt), and other are very effective for migraines, but are not proven to be as safe. Pregnancy registries in the US have information on over 1,500 women who took a triptan during pregnancy and so far the drugs look safe for the baby. A new study from Norway in the February issue of Headache reports on another 1,535 women who took triptans during pregnancy and compared them to 68,000 women who did not. This study also found no increased risk of congenital malformation, even if triptans were taken in the first trimester. Women who took triptans in the second and third trimester also had healthy babies, but they had a slightly increased risk of atonic uterus and bleeding during labor.
Read MoreThere are several effective preventive medications for migraine headaches, however they are prescribed to only a small number of people who could benefit from them. A study by Dr. Richard Lipton in the journal Cephalagia and his colleagues discovered that only 13% of migraine sufferers are taking preventive medications, but those who do have significantly less disability than those who don’t. Among possible reasons, doctors who don’t realize how disabling migraines are, patients how think that medications are dangerous or will cause side effects. Cost does not seem to be a factor because all patients in this study had insurance and most of these medications are inexpensive. Patients are often reluctant to take medications, but would rather find and remove the cause. Unfortunately, in most cases migraine is a genetic disorder and true cure is not possible. However, for most migraine sufferers it is possible to find and remove triggers which make headaches worse. If this is not sufficient, magnesium, CoQ10, other supplements, biofeedback, Botox injections, and regular exercise can provide relief without drugs. If all this still does not provide relief, medications, such as anti-depressants, epilepsy drugs, and high blood pressure drugs can be very effective and improve the quality of life.
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